FDA Inspection
Intarcia Therapeutics, Inc.Intarcia Therapeutics, Inc. – FDA Inspection, Aug 3, 2017
Record Details
This FDA Inspection record concerns Intarcia Therapeutics, Inc., with an inspection on August 3, 2017, issued by the San Francisco District Office, covering human drugs.
- People
- Ashar P. Parikh
- Chengjiu Hu (Issuing Officer)
- Eileen A. Liu
- James A. Lane (FDA Associated Person)
View Company Profile
ID · 4c500167-8bf5-4977-a32c-576495eb43c0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1020235
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.80(a)Written Procedures Not Followed
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